Regulatory Affairs CMC, External Engagement and Advocacy. Andrew has over 30 years pharma and biopharma industry experience working in drug discovery before transitioning into CMC regulatory affairs. In recent years, at Amgen, Andrew’s focus has been on science and risk-based approaches to accelerate CMC in product development to get products into the clinic faster and accelerating the launch of new, innovative drugs.  Andrew is experienced in the development of several types of integral drug-device combination product and through EFPIA has been developing regulatory strategies for the platform device concept.